TELMISARTAN 80 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Telmisartan Aurovitas, 40 mg, tablets
3. Telmisartan Aurovitas, 80 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet:
4. What is Telmisartan Aurovitas and what is it used for
5. Important information before taking Telmisartan Aurovitas
   1. When not to take Telmisartan Aurovitas
   2. Warnings and precautions
   3. Children and adolescents
   4. Telmisartan Aurovitas and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Telmisartan Aurovitas contains sodium
6. How to take Telmisartan Aurovitas
   1. Taking more than the recommended dose of Telmisartan Aurovitas
   2. Missing a dose of Telmisartan Aurovitas
7. Possible side effects
   1. Some side effects can be serious and require immediate medical attention
   2. Possible side effects of Telmisartan Aurovitas:
   3. Reporting side effects
8. How to store Telmisartan Aurovitas
9. Contents of the pack and other information
   1. What Telmisartan Aurovitas contains
   2. What Telmisartan Aurovitas looks like and contents of the pack
   3. Pack sizes:
   4. Marketing authorization holder and manufacturer
   5. Marketing authorization holder:
   6. Manufacturer/Importer:
   7. This medicine is authorized in the Member States of the European Economic Area under the following names:
   8. France:
   9. Germany:
   10. Netherlands:
   11. Poland:
   12. Portugal:
   13. Spain:
   14. Date of last revision of the package leaflet: 01/2025

Package Leaflet: Information for the User

Telmisartan Aurovitas, 40 mg, tablets

Telmisartan Aurovitas, 80 mg, tablets

Telmisartan

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you; do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Telmisartan Aurovitas and what is it used for
• 2. Important information before taking Telmisartan Aurovitas
• 3. How to take Telmisartan Aurovitas
• 4. Possible side effects
• 5. How to store Telmisartan Aurovitas
• 6. Contents of the pack and other information

1. What is Telmisartan Aurovitas and what is it used for

Telmisartan Aurovitas belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is a substance produced by the body that causes blood vessels to narrow, leading to increased blood pressure. Telmisartan Aurovitas blocks the action of angiotensin II, causing blood vessels to relax and blood pressure to decrease.
Telmisartan Aurovitas is used to treat essential hypertension (high blood pressure) in adults. Essential hypertension means that the high blood pressure is not caused by another condition.
Untreated high blood pressure can cause damage to blood vessels in various organs, which can lead to heart attack, heart failure, kidney failure, stroke, or vision loss. Usually, there are no symptoms of high blood pressure before these complications occur.
Therefore, it is essential to regularly check blood pressure to ensure it is within the normal range.
Telmisartan Aurovitas is also used to reduce the risk of cardiovascular events (such as heart attack or stroke) in adults at risk, i.e., those with reduced blood flow to the heart or legs, those who have had a stroke, or those with diabetes. Your doctor will inform you if you are at risk of these events.

2. Important information before taking Telmisartan Aurovitas

When not to take Telmisartan Aurovitas

• If you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• If you are more than 3 months pregnant. (You should also avoid taking Telmisartan Aurovitas during early pregnancy - see section "Pregnancy").
• If you have severe liver problems, such as cholestasis or biliary obstruction (problems with bile flow from the liver and gallbladder) or any other severe liver disease.
• If you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren. If any of these situations apply to you, inform your doctor or pharmacist before taking Telmisartan Aurovitas.

Warnings and precautions

Before taking Telmisartan Aurovitas, discuss with your doctor if you have or have had any of the following conditions or diseases:

• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys).
• Liver disease.
• Heart problems.
• High aldosterone levels (water and salt retention in the body, accompanied by mineral imbalance in the blood).
• Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive water loss from the body) or have low salt levels due to diuretic use, low-salt diet, diarrhea, or vomiting.
• High potassium levels in the blood.
• Diabetes.

Before taking Telmisartan Aurovitas, discuss with your doctor if you are taking any of the following blood pressure-lowering medicines:

• ACE inhibitors (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals. See also the information under the heading "When not to take Telmisartan Aurovitas".

• If you are taking digoxin.

Inform your doctor if you are pregnant or think you might be pregnant. Telmisartan Aurovitas is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the baby (see section "Pregnancy").
In case of planned surgery or anesthesia, inform your doctor that you are taking Telmisartan Aurovitas. Telmisartan Aurovitas may be less effective in lowering blood pressure in black patients.
If you experience stomach pain, nausea, vomiting, or diarrhea after taking Telmisartan Aurovitas, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Telmisartan Aurovitas on your own.

Children and adolescents

Telmisartan Aurovitas is not recommended for use in children and adolescents under 18 years of age.

Telmisartan Aurovitas and other medicines

Inform your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Your doctor may recommend changing the dose of these medicines or taking other precautions. In some cases, it may be necessary to stop taking one of the medicines. This is especially true for the following medicines taken with Telmisartan Aurovitas:

• Lithium-containing medicines used to treat certain types of depression.
• Medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics (some diuretics), ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen), heparin, immunosuppressive agents (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially when taken in high doses with Telmisartan Aurovitas, as they may lead to significant water loss and low blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also the information under the heading "When not to take Telmisartan Aurovitas" and "Warnings and precautions").
• Digoxin.

The effect of Telmisartan Aurovitas may be reduced when taken with non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen) or corticosteroids.
Telmisartan Aurovitas may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that may cause a decrease in blood pressure (e.g., baclofen, amifostine).
Additionally, low blood pressure may be exacerbated by: alcohol, barbiturates, narcotics, or antidepressants. The symptom is dizziness when standing up. If you need to adjust the dose of another medicine you are taking while taking Telmisartan Aurovitas, consult your doctor.

Pregnancy and breastfeeding

Pregnancy
Inform your doctor if you are pregnant or think you might be pregnant. Usually, your doctor will advise you to stop taking Telmisartan Aurovitas before planned pregnancy or as soon as you know you are pregnant, and recommend another medicine instead of Telmisartan Aurovitas. Telmisartan Aurovitas is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the baby if taken after 3 months of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Telmisartan Aurovitas is not recommended during breastfeeding. Your doctor may choose another treatment during breastfeeding, especially for newborns and premature babies.

Driving and using machines

Some patients taking Telmisartan Aurovitas may experience dizziness or fatigue. In such cases, do not drive or operate machinery.

Telmisartan Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Telmisartan Aurovitas

Always take Telmisartan Aurovitas exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose of Telmisartan Aurovitas is one tablet per day. Try to take the tablet at the same time each day. Telmisartan Aurovitas can be taken with or without food. Swallow the tablet with water or another non-alcoholic drink.
It is important to take Telmisartan Aurovitas every day, unless your doctor tells you to stop. If you feel that the effect of Telmisartan Aurovitas is too strong or too weak, consult your doctor or pharmacist.
In the treatment of high blood pressure, the usual dose of Telmisartan Aurovitas is 40 mg once daily for most patients, which provides 24-hour blood pressure control. Your doctor may recommend a lower dose of 20 mg once daily or a higher dose of 80 mg once daily. Telmisartan Aurovitas can also be given in combination with a diuretic (e.g., hydrochlorothiazide), which enhances the blood pressure-lowering effect of Telmisartan Aurovitas.
To reduce the risk of cardiovascular events, the usual dose of Telmisartan Aurovitas is 80 mg once daily. At the start of treatment, blood pressure should be monitored frequently.
In patients with liver problems, the recommended dose should not exceed 40 mg once daily.

Taking more than the recommended dose of Telmisartan Aurovitas

If you accidentally take too many tablets, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department.

Missing a dose of Telmisartan Aurovitas

If you miss a dose, take it as soon as you remember, then continue taking your medicine as usual. If you do not take a tablet during the entire day, take your usual dose the next day. Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Telmisartan Aurovitas can cause side effects, although not everybody gets them.

Some side effects can be serious and require immediate medical attention

If you experience any of the following symptoms, contact your doctor immediately:
Septicemia* (also known as blood poisoning, a severe infection with an inflammatory reaction throughout the body), angioedema (swelling of the skin and mucous membranes); these side effects are rare (may affect up to 1 in 1,000 people) but are very serious, and you should stop taking the medicine and contact your doctor immediately. If these symptoms are not treated, they can be fatal.

Possible side effects of Telmisartan Aurovitas:

Common side effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in patients treated to reduce the risk of cardiovascular events.
Uncommon side effects (may affect up to 1 in 100 people):
Urinary tract infections, upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), decreased red blood cell count (anemia), high potassium levels in the blood, difficulty sleeping, low mood (depression), fainting, spinning sensation (peripheral vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness when standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhea, discomfort in the abdomen, bloating, vomiting, itching, excessive sweating, rash, back pain, muscle spasms, muscle pain, kidney problems, including acute kidney failure, chest pain, feeling weak, and increased creatinine levels in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
Septicemia* (also known as blood poisoning, a severe infection with an inflammatory reaction throughout the body, which can be fatal), increased eosinophil count, low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reactions (e.g., rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in patients with diabetes), feeling anxious, drowsiness, vision disturbances, fast heart rate (tachycardia), dry mouth, gastritis, liver function disorders (more common in patients of Japanese origin), angioedema, which can also be fatal (also known as angioedema, which can be fatal), skin eruption (skin disease), skin redness, hives, severe drug rash, joint pain, limb pain, tendon pain, flu-like symptoms, decreased hemoglobin levels (protein in the blood), increased uric acid levels, increased liver enzyme activity or creatine phosphokinase in the blood.
Very rare side effects (may affect up to 1 in 10,000 people):
Progressive scarring of lung tissue (interstitial lung disease)**
Frequency not known (cannot be estimated from the available data):
Angioedema of the intestine - after taking similar medicines, angioedema of the intestine has occurred with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
* The event may be coincidental or related to an unknown mechanism.
** Cases of progressive scarring of lung tissue have been reported with telmisartan. It is not known whether telmisartan causes this.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Telmisartan Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after EXP.
The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Store in the original package to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Telmisartan Aurovitas contains

• The active substance is telmisartan.

Each tablet contains 40 mg of telmisartan.
Each tablet contains 80 mg of telmisartan.

• The other ingredients are: mannitol, meglumine, povidone (K 25), sodium hydroxide, colloidal silica, and sodium stearyl fumarate (see section 2).

What Telmisartan Aurovitas looks like and contents of the pack

Tablet.
Telmisartan Aurovitas, 40 mg, tablets:[Size: approximately 13 x 5.9 mm]
White or almost white, oblong, biconvex, uncoated tablets with "N" and "40" engraved on one side and a score line on the other side. The tablet can be divided into equal doses.
Telmisartan Aurovitas, 80 mg, tablets:[Size: approximately 16.2 x 7.8 mm]
White or almost white, oblong, biconvex, uncoated tablets with "N" and "80" engraved on one side and a score line on the other side. The tablet can be divided into equal doses.
Telmisartan Aurovitas tablets are available in blisters.

Pack sizes:

Telmisartan Aurovitas, tablets, 40 mg, 80 mg: 14, 28, 30, 50, 56, 84, 90, 98, and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João De Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This medicine is authorized in the Member States of the European Economic Area under the following names:

France:

Telmisartan Arrow 40 mg/ 80mg, comprimé sécable

Germany:

Telmisartan PUREN 20 mg/ 40 mg/ 80 mg Tabletten

Netherlands:

Telmisartan Aurobindo 20mg/ 40 mg/ 80 mg, tabletten

Poland:

Telmisartan Aurovitas

Portugal:

Telmisartan Generis Phar

Spain:

Telmisartán Aurovitas 20 mg/ 40 mg/ 80 mg comprimidos EFG

Date of last revision of the package leaflet: 01/2025